Skepticism

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Universality of lazy science

Kris Wager reports on the ongoing reproducibility crisis in Chinese research — as he mentions, it’s being called “fraud”, but that may be too strong a word, unless you want to call a lot of American science fraudulent, too. We’re in a strange state right now where the pursuit of arbitrary statistical validity at all costs has led to some distortion of our results.

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I think it’s more that there’s money riding on the “scientific” paper that results.

Not the scientific *answer* – it’s always been fine and good for industry and technology to care what the science really is. But we find ourselves in a place where having a wanted result can be long-term profitable to many people even though it’s false.

(Sigh. The way out is even simple: spend a fuckton of public money on drug R&D, and demand that the resulting work stay patent-free. No need for reform, just stop handing over what should clearly be a public job to private interests.)

All of this relates to the testing of western-style medicines, apparently. It’s not clear to me to what extent any western companies are involved. However, it would be unfortunate if the effect of these reports in China were to increase the popularity of “traditional medicines” based on ingredients like rhino horn.

@ #1, your idea won’t work due to the economics of drug development. Simply put, the cost of bringing a drug to market runs into the hundreds of millions of dollars (rumours put some recent approved drug costs at over a billion each), meaning that no public health-funding agency has a budget even vaguely close to being able to support the drug development process. And no drug company is going to spend the money on developing a unpatentable drug – without that patent any other company could start producing the drug, all without having to contribute to the $100’s of millions+ that the first company spent in R&D and trials.

There are ways to resolve the reproducible issues with drug trials (e.g. having all trials run by 3rd party organisations/companies, using standardised protocols, with mandatory reporting of results), but riding the world of drug patents isn’t one of them.

your idea won’t work due to the economics of drug development. Simply put, the cost of bringing a drug to market runs into the hundreds of millions of dollars (rumours put some recent approved drug costs at over a billion each), meaning that no public health-funding agency has a budget even vaguely close to being able to support the drug development process.

Then increase the budgets of those agencies through taxes if need be, and whatever isn’t covered by taxes would be paid by the customers who would’ve been handing money to a private company. Why wouldn’t that work? What is the special magic sauce that private entities have and public ones don’t, such that somehow the former are economical and the latter aren’t?

And no drug company is going to spend the money on developing a unpatentable drug

Um, obviously? The reason you’d make it unpatentable is so that the public (not a private company) would have the rights to it. So clearly we would make it, if it’s worth making, since there’s no need whatsoever for us to rely on a drug company making it and piling billions of dollars of profit on top, which isn’t doing anything useful for us.

– without that patent any other company could start producing the drug, all without having to contribute to the $100’s of millions+ that the first company spent in R&D and trials.

If some company wants to try to make a profit by selling an unpatentable drug, which is publicly owned and was publicly developed to do something useful for people and not to make a profit for anybody, I guess we could allow it if the company satisfies all of the necessary regulations (although it very well could be disallowed), and that company’s profits can be taxed. That company’s taxes can go to the public health agencies which had to pay for R&D of this drug, for which that private company has no right except the right to produce/sell it and potentially profit from that sale. But the public is not in the business of ensuring such companies can make huge profits and keep it to themselves. If they can’t make enough profit, because they are competing with a public entity that isn’t attempting to profit off of people’s health problems, then no one is forcing them to engage in that kind of business. They can make money some other way, and it is no loss to the rest of us, because we got the drugs we needed and did the research we needed and paid as much as we needed to pay for them.

@ #1, your idea won’t work due to the economics of drug development. Simply put, the cost of bringing a drug to market runs into the hundreds of millions of dollars (rumours put some recent approved drug costs at over a billion each), meaning that no public health-funding agency has a budget even vaguely close to being able to support the drug development process.

Save, for very special cases, such as the two Ebola vaccines, which were paid for substantially by public funding.
So, due to a lack of funding for the funding agencies, it’s only a rarity, not an impossibility.

The drug companies are know for their lack of honesty in the publicly released costing of their drug development. Example, this from Tufts, claiming 2.6 billion per drug approved for the market. They include things like what they could have earned on the monies by investing them in other stocks, the lack of royalties from the time they start their clinical trials, and, of course, their advertising costs, which might be double of the actual costs of developing that one drug. Tufts gets monies from the pharmaceutical industry, so that makes their figures suspect.

Being somewhat attached to the industry, the figures I saw tended to be closer to 500 million for small molecules (MW <500-600 Daltons), rising to a billion for the newer anti-arthritis/cancer biologics, For many small molecules, the breakdown was about 20-30 million for the discovery, early testing, and development of chemical processes and analytical methods up to ICH (FDA enforces ICH standards, where applicable, in the US) standards. The manufacturing of the larger batches for clinical trials could run another 20-30 million (the size of these batches are based on early sales estimates). Somewhere in the mix was drug product formulation, another 10-15 million. I worked on the chemical processes.

The rest of the costs was for the Clinical Trials, also run under ICH guidelines.

The Pharma industry executives might complain about being highly regulated (they could be jailed for not following FDA guidelines, although that requires knowingly disobeying the regulations), they do want to live up to ICH guidelines, as that allows them with a clinical trial anywhere in the ICH community to have the results be accepted by all member nations, and their products accepted by the member nations. Developed in the USA, clinical trials run in Europe (lower informed consent rules), and sales to Europe, Japan, and the US under one regulatory umbrella.

Though this seems to be getting away from the OP, a few comments about :

1. The reason why drug development costs have gotten completely out of control is that drug companies have no incentive to reign in costs. Why bother when they have a guaranteed market that must pay whatever they charge? Consumers have no choice but to buy life-saving drugs, and at any rate, Uncle Sam buys most of them through Medicare, Medicaid, the VA, etc. At least the latter two can negotiate the price somewhat, but Medicare can’t even do that since Republicans axed the idea when Medicare Part D was passed. (Thanks, Obama’s time-machine!)

2. More generally, the problem with excessive health care costs is due to a combination of inelastic demand (can’t stop buying a life-saving drug or procedure just because it costs to much, even if you could haggle over it in the middle of a heart attack) and insufficient competition (caused by patents, mostly, but other reasons too). Trying to shame the drug companies into not gouging us isn’t serious. They’ll just walk back the massive increase on epi-pens a little bit while still jacking up everything else.

3. There’s no particular need, nor is it probably a good idea, to nationalize drug development. Price controls are what are needed. Virtually every other country does this with significant success, so it’s not like it’s some radical idea that hasn’t been tried. And anyone who thinks that drug reimportation is a good idea (which includes a certain president-elect who will of course change his mind as soon as he’s properly induced by powerful interests) implicitly agrees with price controls. All reimportation does is piggy-back on another country’s price controls, so it would make far more sense just to cut out the middle-man and do it here. But we can’t, because that would be socialism, and American Exceptionalism FTW.